Exercise Prehab in Older Adults With Hematologic Malignancies

NCT02791737 | Completed Results DMC

• 2 other identifiers: OSU-16016NCI-2016-00446
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies a structured exercise program intervention in improving physical activity in older patients with hematologic malignancies undergoing cancer therapy. Patients with hematologic malignancies are at an increased risk of functional dependence and injury. Structured exercise programs, such as the Otago exercise programme (OEP), may improve balance, strength, and prevent fall-related injury in older patients with hematologic malignancies undergoing cancer therapy.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Keywords

Hematologic Malignancy; Exercise; Decreased Physical Activity

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0

  Adverse Events and their severity will be captured and graded according to Common Terminology Criteria for Adverse Events Version 5.0, and whether any events can be attributed to exercise.

  Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

• Percentage of Eligible Patients Completing the OEP

  Feasibility defined as 80% of eligible of patients completing the OEP. The proportion of screened patients who agree to participate, the proportion of patients who attend certain percentage of assigned physical therapy (PT) sessions and the proportion of patients who complete the whole study along will be described with respective 95% confidence intervals. Study implementation and challenges will be evaluated by patient exercise logs. Exercise levels at home will also be assessed by exercise diary log

  Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

Secondary Outcomes (10)

• Biomarker Expression Levels

  Study Visit 1 (Baseline), and study visit 3 (6 months)

• Change in Geriatric Assessment (GA) Measured Using The Cancer and Aging Research Group (CARG) Geriatric Assessment (G)A-patient Reported Karnofsky Performance Status (KPS) for Patients Undergoing Transplant

  Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

• Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)

  Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

• Health Related Quality of Life (HRQL) Measured Using the PROMIS

  Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)

• Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant

  Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

Study Arms (1)

Supportive care (otago exercise programme)

EXPERIMENTAL

Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Exercise Intervention BEHAVIORAL

Complete individualized exercise program

Supportive care (otago exercise programme)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (otago exercise programme)

Physical Therapy PROCEDURE

Complete individualized exercise program

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Supportive care (otago exercise programme)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (otago exercise programme)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (otago exercise programme)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hematologic malignancy receiving care (chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) for their hematologic malignancy at the Ohio State University
• Impairments in physical function, as defined by a score \< 9 on the SPPB pre-screen
• Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Prisoners
• Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Rosko A, Huang Y, Jones D, Presley CJ, Jaggers J, Owens R, Naughton M, Krok-Schoen JL. Feasibility of implementing an exercise intervention in older adults with hematologic malignancy. J Geriatr Oncol. 2022 Mar;13(2):234-240. doi: 10.1016/j.jgo.2021.07.010. Epub 2021 Aug 24.

  PMID: 34446377 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Hematologic Neoplasms; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Dr. Ashley Rosko
• Organization: The Ohio State University Comprehensive Cancer Center

Ashley.Rosko@osumc.edu

614-293-3196

Study Officials

• Ashley Rosko, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: August 15, 2016
• Primary Completion: July 31, 2018
• Study Completion: January 6, 2019
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

US (1)